1. Field of the Invention
The present invention discloses an iodine-containing nasal moisturizing saline solution and a method for the prevention and/or treatment of sinusitis and related conditions associated with nasal congestion. The nasal moisturizing saline solution is buffered, isotonic, and contains at least 0.001% iodine by weight. In the method for the prevention and/or treatment of sinusitis and related conditions associated with nasal congestion, the iodine-containing nasal moisturizing saline solution is administered to the nostrils of a patient in need thereof.
2. Description of the Related Art
The nose is a specialized structure that serves dual functions as the organ for the sense of smell and as an entry to the respiratory tract. Nerve receptor cells within the nose detect odors that enter via the nostrils and transmit signals to the brain through the olfactory nerve. The sense of smell also enhances the sense of taste. The ability to smell is more refined than the ability to taste. Therefore, when a cold blocks nasal passages, food may seem bland or even tasteless.
As part of the respiratory tract, the nose moisturizes and warms incoming air and filters out foreign materials. Small glands within the lining of the nose secrete mucus, a sticky substance that lubricates the walls of the nose and throat. Mucus humidifies the incoming air and traps bacteria, dust, and other particles entering the nose. Many bacteria are dissolved by chemical elements in the mucus or transported to the entrance of the throat by the tiny, hairlike structures called cilia. In the throat, bacteria are then swallowed and killed by acids and other chemicals produced in the stomach. This line of defense protects the body against the billions of bacteria that continually enter the nose.
Connected to the nose are sinuses or air-filled cavities located within certain facial bones. There are four groups of sinuses, namely, frontal, sphenoidal, ethmoidal, and maxillary. The sinuses are lined with a mucous membrane and are normally kept clear when mucus drains through them into the nasal passages. If they are obstructed for any reason, such as from the congestion present during a cold, normal drainage cannot occur and infection of the sinuses can result.
Sinusitis and inhalant allergy are two of the most common conditions affecting the nasal passages. Sinusitis is an infection, usually bacterial, of one or more of the sinuses. A sinus infection may be triggered by anything that prevents the mucus in the sinuses from draining properly into the nasal passages. Possible causes include swimming and diving, injuries, abnormal structure of the facial bones, congestion from the flu or a cold, allergies, or an abscess in a tooth which may penetrate the sinuses and allow bacteria to enter them. Many different types of bacteria can cause sinusitis, including some of the same strains that lead to pneumonia, laryngitis, and middle ear infections.
Sinusitis is characterized by pain and tenderness above the infected sinus, which is felt in the face and forehead, behind the eyes, in the eyes, near the upper part of the nose, and even in the upper teeth. This facial pain may be accompanied by headache, slight fever, chills, sore throat, nasal obstruction, and a discharge of pus from the nose.
Sinusitis usually lasts about two weeks, with the pain often subsiding in the morning and worsening as the day goes on, or fluctuating as the patient moves about and changes positions. There is evidence that smokers are more likely to suffer from sinusitis than are nonsmokers. Those who frequently have colds are also more susceptible to sinusitis. Avoiding smoking and exposure to persons with colds may help to prevent sinusitis.
The sinuses cannot be seen directly, so diagnostic evaluation may include X-ray examination to check for the presence of fluid or abnormalities in the sinuses and to determine which of the sinuses are infected. Computed tomography is an excellent tool for evaluating serious sinus problems.
Sinusitis is treated by encouraging drainage of the sinuses. Nasal decongestants, nasal moisturizers, and moist heat work to aid sinus drainage. The nasal moisturizers may be in the form of a nasal spray or nasal drops. In addition, physicians will usually prescribe an antibiotic that will kill the bacteria that most commonly trigger sinusitis.
Inhalant allergens are those that are breathed in, including such substances as dust, pollen, feathers, and animal dander. Hay fever is an inhalant allergy in which the mucous membranes react to various inhaled substances, usually the pollens associated with the changing seasons. Year-round "hay fever" may actually be a reaction to pet dander, feather, mold, or dust.
The symptoms of hay fever are usually the same, regardless of the allergen. Common symptoms include itching of the nose and roof of the mouth; a thin watery discharge constantly draining from the nose; itchy, watery eyes; sneezing; headache; irritability; a feeling of exhaustion; insomnia; loss of appetite; and in advanced cases, coughing and wheezing.
A severe case of hay fever may be best treated by changing the environment, that is by removing the allergen causing the trouble or reducing the patient's exposure to it. Those who react to weed pollen may need to move to a more urban location with a lower concentration of pollen in the air. Many hay fever suffers will benefit from using an air conditioner, which filters the air and thus keeps pollen levels in the home to a minimum. There is no way to prevent hay fever, but avoiding the allergens as much as possible may at least help to relieve some of the discomfort.
Several medications are available for the hay fever sufferer: oral antihistamines, which counteract the histamine that is released by the body in reaction to the allergen; corticosteroids, which reduce inflammation; eye drops, which relieve itching and redness; and desensitization shots, which cause the body to develop tolerance to the allergen. In addition, nasal moisturizers work to aid sinus drainage. The nasal moisturizers may be in the form of a nasal spray or nasal drops.
Several nasal moisturizers are presently commercially available as over-the-counter or non-prescription medications, e.g., Afrin.RTM. Moisturizing Saline Mist, Ayr.RTM. Saline Nasal Mist, NaSal.TM. Saline Moisturizer, and Ocean.RTM.. Basic nasal moisturizers are made of an aqueous solution of sodium chloride, a preservative, and a buffer.
Numerous examples of nasal solutions, methods of use, and variations thereof have been reported. For example, U.S. Pat. No. 5,622,724 (Bryce-Smith) discloses a method for treating the symptoms of the common cold by administering a spray solution containing a nontoxic, symptom effective treating amount of a solution of a substantially unchelated ionic zinc compound to the nostrils and respiratory tract of a patient.
U.S. Pat. No. 5,562,908 (Geria) discloses nasal compositions effective for relieving mammalian sinus headache associated with inflamed or congested turbinates, containing an anesthetically effective amount of a non-addictive, rapidly absorbable anesthetic component, i.e., an acid addition salt of dyclonine or pramoxine. The anesthetic component is the sole active ingredient in the composition or is combined with a decongestant of the sympathomimetic amine class.
U.S. Pat. No. 5,508,282 (Tulin-Silver et al.) discloses a stable, non-irritating composition and method for treating, without side effects, acute or chronic rhinosinusitis and its associated upper airway symptoms. The composition and treatment are useful for relieving the symptoms, and shortening the duration, of acute or chronic rhinosinusitis. The composition comprises a therapeutically effective solution having a pH of about 6.0, of ascorbic acid and caffeine, in combination with other soluble vitamins, natural ingredients and preservatives in a pharmaceutically acceptable carrier. The method includes the steps of preparing and administering the composition to the nasal membranes of a patient in the form of a nasal spray or drops.
U.S. Pat. No. 5,478,565 (Geria) discloses a topically applicable nasal composition capable of relieving mammalian sinus headache. The composition contains (i) an anesthetically effective amount of an acid addition salt of dyclonine or pramoxine and (ii) an adrenergically effective amount of an acid addition salt of a sympathomimetic amine decongestant selected from the group consisting of an arylalkylamine, imidazoline and a cycloalkylamine incorporated in a pharmaceutically acceptable carrier.
U.S. Pat. No. 5,169,849 (Kiechel et al.) discloses a liquid nasal pharmaceutical composition which contains as an active agent a pharmaceutically effective amount of dihydroergotamine which is capable of depressing the ciliary function and an effective amount of a xanthine which is capable of increasing the ciliary function. The weight ratio of the dihydroergotamine to the xanthine is from 0.1:1 to 10:1.
U.S. Pat. No. 4,940,728 (Postley) discloses a method for treating sino-nasal congestion, viral nasopharyngitis, allergic rhinitis, and related conditions associated with nasal congestion. The method comprises applying to the nasal mucosa a solution comprising ascorbic acid, a pharmaceutically acceptable salt or ester of ascorbic acid, or combinations thereof dissolved in a pharmaceutically acceptable liquid carrier in an amount effective to treat sino-nasal congestion.
U.S. Pat. No. 4,603,131 (Bernstein et al.) discloses a method and composition for preventing irritation of a mucous membrane of the nose caused by allergies, chemical pollutants, or physical irritants manifested by sneezing, discomfort, stuffiness or mucous discharge. The method comprises applying topically to a mucous membrane of the nose a therapeutically effective amount of a tri-cyclic anti-depressant.
Iodine is a halogen element of a peculiar odor and acrid taste. Iodine is characterized by the chemical symbol I, has an atomic number of 53, and an atomic weight of 126.904. It is a nonmetallic element, occurring in heavy, grayish black plates or granules. Iodine is essential in nutrition, being especially abundant in the colloid of the thyroid gland. One gram of iodine dissolves in 2950 ml of water or in 12.5 ml alcohol. Internally, iodine is used for treatment of goiter, hyperthyroidism, and as an antidote to alkaloid poisons. Topically, iodine has been used as an antiseptic.
In addition, iodine has been used to destroy viruses. For example, U.S. Pat. No. 4,355,021 discloses a substantially dry, impregnated wipe having iodine and a means for retaining the iodine. The iodine is present in the wipe in an amount from about 1% to about 15% by weight of the wipe and in an amount sufficient to provide virucidal activity. The iodine is preferably present in an amount of from about 2% to about 5%. A flexible paper is preferred, and the most preferred substrate is facial tissue.
However, none of the cited patents disclose a nasal moisturizing solution containing iodine. It is, therefore, an object of this patent application to disclose an iodine-containing nasal moisturizer solution. The iodine-containing nasal moisturizer solution is useful for the prevention and/or treatment of sinusitis, sino-nasal congestion, acute or chronic rhinosinusitis, viral nasopharyngitis, allergic rhinitis, inhalant allergy, and related conditions associated with nasal congestion.
It is a further object of this patent application to disclose a method of use for the iodine-containing nasal moisturizer solution, where the solution is used to prevent and/or treat sinusitis, sino-nasal congestion, acute or chronic rhinosinusitis, viral nasopharyngitis, allergic rhinitis, inhalant allergy, and related conditions associated with nasal congestion.